Vardenafil therapy for patients with pulmonary arterial hypertension. A one-year, multicentre, open-label study

Zhi-Cheng Jing ^1*, Xin Jiang ¹, Bing-Xiang Wu ², Xi-Qi Xu ³, Yan Wu ⁴, Chuan-Rong Ma ¹, Yong Wang ⁵, Yue-Jin Yang ⁴, Jie-Lin Pu ⁴ and Wen Gao ⁶

¹ Department of Pulmonary Circulation,Shanghai Pulmonary Hospital, China
² Department of Cardiology, First Affiliated Hospital, Haerbin Medical University, Haerbin, China
³ Department of Internal Medicine, Aviation Industry Central Hospital, Beijing, China
⁴ Department of Cardiovascular Medicine, Cardiovascular Institute and Fu Wai Hospital,Beijing, China
⁵ Department of Respiratory Medicine, Beijing Shijitan Hospital, Peking University, Beijing, China
⁶ Department of Thoracic Surgery,Shanghai Pulmonary Hospital, China

^* To whom correspondence should be addressed. E-mail: jingzhicheng{at}gmail.com.

Accepted 4 June 2009

Abstract

Background: Vardenafil is a new phosphodiesterase-5 (PDE5) inhibitor that has shown some efficacy in the treatment of pulmonary arterial hypertension (PAH). As yet, however, no large clinical studies examining its long-term effects in patients with PAH have been conducted.

Methods: A multicentre, open-label study of one-year's duration was undertaken in 45 patients with PAH to determine the long-term safety and efficacy of vardenafil (5 mg once daily for the first 4 weeks, then 5 mg twice daily) and make a preliminary assessment of its monthly acquisition cost versus other PAH-active therapies. The patients' clinical features, exercise capacity, WHO functional class, and haemodynamic variables were measured at baseline and at 3 and at least 9 months after initiating vardenafil therapy.

Results: At the 3 months and 14 ± 3 months (range, 9 to 18 months) follow-up assessments, the 6-minutes walking distance (6MWD) was significantly increased from baseline by 70.7 ± 78.4 metres (p <0.0001) and 83.4 ±91.8 metres (p <0.0001), respectively. Furthermore, long-term treatment with vardenafil for a mean duration more than one year was also associated with improvements in haemodynamic parameters, WHO functional class and serum uric acid concentrations. Overall, vardenafil treatment was well tolerated. No patients were withdrawn due to adverse events, and none died during the course of the study.

Conclusion: Long-term treatment with vardenafil is well tolerated and has sustained beneficial effects on PAH, as measured by patients¡ exercise capacity, WHO functional class, and haemodynamic parameters.